Disqualification Of Testing Facilities PDF

# Disqualification of Testing Facilities ## Purpose Disqualification may serve the following purposes: 1. To exclude from being considered the completed studies that were performed by a facility that has failed to comply with GLP regulations until it can be proved that such non-compliances did no...

# Disqualification of Testing Facilities ## Purpose Disqualification may serve the following purposes: 1. To exclude from being considered the completed studies that were performed by a facility that has failed to comply with GLP regulations until it can be proved that such non-compliances did not occur during a particular study or that the non-compliances did not affect the acceptability of data generated during that study. 2. To exclude from being considered, all the studies that have been completed following disqualification until the facility undertakes to conduct studies according to GLP regulations. If a testing facility is disqualified, the sponsor of the study that was performed (and disqualified) cannot use that as an excuse to not submit the study in their application for research or marketing permit. They must get the study repeated and submit with the application. ## Disqualification Grounds Reasons why a testing facility may be disqualified include: - Failure to comply with one or more of the GLP regulations. - The non-compliance has created an adverse effect on the validity of the study. - Previous incidents of warnings or individual study rejections have not helped to achieve compliance with GLP guidelines. When the FDA has relevant information to justify a test facility disqualification, the Commissioner issues a written notice to the concerned facility proposing the disqualification. A regulatory hearing will then be conducted as per legal guidelines. ## Final Disqualification Order After the regulatory hearing, or after time permitted for a contest by the facility passes without such action, the Commissioner of FDA evaluates the records of the proceedings and issues the final order to disqualify the facility, with the reason for the disqualification. A copy of this order must be sent to the testing facility. ## Actions Following Disqualification After disqualification of a testing facility, scrutiny is done of every application for research or marketing permit that contains data from a study conducted by the disqualified testing facility. It is determined if that study is acceptable or not. If the study is considered unacceptable, the onus lies on the study sponsor to prove that the study was unaffected by the non-compliances that led to the disqualification. This may include validating the data by a repeat study. Any study done by a disqualified testing facility will be invalid for the purpose of application for a research or marketing permit, unless the facility has been reinstated after due procedure. ## Public Disclosure of Disqualification After a testing facility has been disqualified by the final order, the FDA Commissioner notifies all interested persons at his discretion if he believes the disclosure is in public interest, or that it will promote compliance with GLP. If public notice is given, it must include a copy of final disqualification order along with the statement that the FDA will not consider any studies done by the said facility in support of any application for research or marketing permit. ## Termination or Suspension of Testing Facility by Sponsor If a sponsor suspends or terminates a laboratory from further participation in the study, it must notify the FDA in writing within 15 working days, along with the reasons for such action. ## Reinstatement of a Disqualified Testing Facility - The disqualified testing facility may apply to the FDA Commissioner assuring that it will comply with GLP regulations in the future, along with details of the corrective actions that have been taken or are intended to be taken, and the reasons why it believes it must be reinstated. - On examining this submission, and following an inspection, if the Commissioner determines that GLP regulations are being followed, he may reinstate the testing facility as a source for the study. - The testing facility must be notified and any other involved persons, such as the sponsor, and information about the reinstatement is publicly disclosed. Before a new drug is introduced into the market, it has to undergo certain in-vitro and in-vivo experiments in a non-clinical setting.